Retrieval apparatus and methods for use

ABSTRACT

An apparatus for capturing material within a body lumen includes a shaft carrying an expandable basket device on a distal end thereof. The basket device includes a distal basket carried and a proximal basket carried on the shaft such that the proximal basket is proximal to and spaced apart from the distal basket. Each basket includes an open end communicating with an interior of the respective basket and oriented towards one another. In one embodiment, a tubular middle portion extends between the baskets. In another embodiment, the distal basket includes an actuator coupled to the distal basket open end such that movement of the baskets towards one another causes the actuator to direct the distal basket open end inwardly to allow the open end to be received within the proximal basket to facilitate removal of the apparatus after capturing material within the baskets.

RELATED APPLICATIONS

This application claims benefit of co-pending U.S. provisionalapplication Ser. Nos. 61/012,722, filed Dec. 10, 2007 and 61/046,395,filed Apr. 18, 2008, the entire disclosures of which are expresslyincorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus for retrievingmaterial within a body lumen of a patient. More particularly, thepresent invention relates to expandable and/or contractible apparatusfor retrieving thrombus, objects, or other material within a body lumen,such as a blood vessel, aorto-venous fistula, tubular graft, and/orother body lumen within a patient's body, and to methods for making andusing such apparatus.

BACKGROUND

Flow within a blood vessel or other body lumen within a patient'svasculature may be constricted or ultimately interrupted for a varietyof reasons. For example, a vessel may gradually narrow due toinflammation and/or cell proliferation. In addition, thrombus may formdue to such narrowing or other flow problems within a vessel.

For example, an aorto-venous graft may be implanted in an arm of apatient experiencing kidney failure, e.g., to facilitate dialysistreatment. Such grafts may be a fistula formed directly in the patient'sbody, e.g., through tissue between an adjacent artery and vein or othervessels, may be a xenograft implanted between two vessels, or may be asynthetic graft. Such grafts only have a limited life cycle due toinflammation, thrombus formation, and the like. Once such a graftbecomes sufficiently occluded or otherwise deteriorates, a new graftmust be implanted at a new location for subsequent treatment.

Accordingly, apparatus and methods for removing material fromaorto-venous grafts, e.g., to extend the useful life of such grafts,and/or from other blood vessels or body lumens would be useful.

SUMMARY

The present invention is directed to apparatus for retrieving materialwithin a body lumen of a patient, and, more particularly, to expandableand/or contractible apparatus for retrieving thrombus or other materialwithin a body lumen, such as a blood vessel, aorto-venous fistula,and/or other body lumen within a patient's body, and to methods formaking and using such apparatus.

In accordance with a first embodiment, an apparatus is provided forremoving, retrieving, or otherwise capturing material within a bodylumen that includes a shaft or other elongate member including aproximal end, a distal end sized for introduction into a body lumen, andterminating in a distal tip; and a basket device carried on the distalend.

The basket device generally includes a distal basket adjacent the distaltip and a proximal basket proximal to and spaced apart from the distalbasket. Each of the baskets may include an open end communicating withan interior of the respective basket, the open ends oriented towards oneanother. At least one of the proximal and distal baskets may be movabletowards the other for substantially enclosing and capturing materialwithin the interiors of the baskets. Thus, the basket device may includean open region between the proximal and distal baskets that may besubstantially enclosed when the proximal and distal baskets are directedtowards one another.

For example, the elongate member may include a core wire carrying thedistal basket, and an actuator member adjacent the core wire carryingthe proximal basket. Thus, axial movement of the actuator member andcore wire relative to one another may direct the proximal basketdistally towards the distal basket and/or direct the distal basketproximally towards the proximal basket. In one embodiment, the actuatormember may be a tubular body surrounding the core wire such that thecore wire extends distally from a distal end of the tubular body. Thecore wire may be pulled proximally at least partially into the tubularbody, or the tubular body may be advanced distally at least partiallyover the core wire to enclosed the basket device.

In one embodiment, the proximal and distal baskets are expandable from acontracted condition, e.g., sized for introduction into a body lumen,and an expanded condition sized, e.g., for contacting a wall of the bodylumen and/or for capturing material within the open ends of the baskets.

In addition or alternatively, each of the proximal and distal basketsmay include a circumferential wall and a closed end opposite the openend. The circumferential wall may include a plurality of openingstherein, e.g., by forming the baskets from a mesh structure, such as alaser-cut tube or a wire mesh.

In one embodiment, the basket device includes a middle portion extendingbetween the proximal and distal baskets. The middle portion, e.g., amesh tubular structure that may partially engage material capturedbetween the baskets, may have a cross-section that is smaller than theproximal and distal baskets in the expanded condition. The middleportion may be coupled to the proximal and distal baskets such that themiddle portion may be directed laterally, e.g., to accommodate materialbeing received between the baskets adjacent the middle portion. Forexample, the middle portion may be coupled to the baskets by a pluralityof struts, e.g., extending between ends of the middle portion and theopen ends of the proximal and distal baskets. The middle portion may besubstantially flexible such that the middle portion is compressibleaxially when the proximal and distal baskets are moved towards oneanother for capturing material within the interiors of the baskets. Forexample, the struts may bend or otherwise deflect to accommodate themiddle portion being received within the interiors of the baskets as thebaskets are directed towards one another.

Optionally, the apparatus may include a sheath or other tubular member,e.g., for selectively covering and/or exposing the basket device. Thetubular member may include a proximal end, a distal end sized forintroduction into a body lumen, and a lumen extending between thetubular member proximal and distal ends. Before use, the basket devicemay be disposed within the lumen in the contracted condition, e.g.,adjacent the distal end of the tubular member, such that the elongatemember extends proximally within the lumen. The elongate member may bemovable relative to the tubular member for deploying the basket devicefrom the tubular member distal end. For example, the basket device maybe directable to a contracted condition for placement within the tubularmember lumen, and biased to resiliently expand to an expanded conditionupon being deployed from the tubular member.

In addition or alternatively, the apparatus may include one or moreactuators for selectively expanding and/or compressing the basket devicebetween the contracted and expanded conditions. For example, theelongate member may include one or more balloons or other expandablemembers within the basket device that may be expanded to expand thebasket device from the contracted to the expanded condition.

In accordance with another embodiment, an apparatus is provided forretrieving material within a body lumen that includes a core wireincluding a proximal end and a substantially atraumatic distal tip, andan actuator member adjacent the core wire and including a distal enddisposed proximal to the distal tip. A distal basket is fixed axiallyrelative to the core wire adjacent the distal tip and a proximal basketfixed axially relative to the distal end of the actuator member. Thedistal basket may include a proximal open end and a distal enclosed enddefining an interior of the distal basket, and the proximal basket mayinclude a distal open end and a proximal enclosed end defining aninterior of the proximal basket. The basket device also includes amiddle portion extending between the proximal and distal baskets. Themiddle portion may have a cross-section that is smaller than theproximal and distal baskets in the expanded condition.

The actuator member is movable distally relative to the core wire, e.g.,to direct the proximal basket distally towards the distal basket, forsubstantially enclosing and capturing material within the interiors ofthe baskets. The middle portion may be compressible axially when theproximal basket is moved distally towards the distal basket, e.g., toaccommodate receiving the middle portion within the interiors of thebaskets along with material captured therein.

In accordance with yet another embodiment, an apparatus is provided forretrieving material within a body lumen that includes a core wirecomprising a proximal end and a substantially atraumatic distal tip; andan actuator member adjacent the core wire and comprising a distal enddisposed proximal to the distal tip, the actuator member movabledistally relative to the core wire. A distal basket is fixed axiallyrelative to the core wire adjacent the distal tip, the distal basketcomprising a proximal open end and a distal enclosed end defining aninterior of the distal basket; and a proximal basket fixed axiallyrelative to the distal end of the actuator member, the proximal basketcomprising a distal open end and a proximal enclosed end defining aninterior of the proximal basket, the proximal basket movable distallytowards the distal basket when the actuator member is moved distallyrelative to the core wire for substantially enclosing and capturingmaterial within the interiors of the baskets. An actuator collar isslidable on the core wire within the interior of the distal basket, thecollar coupled to the open end of the distal basket such that, when theactuator member is moved distally relative to the core wire, the collarapplies an inward force to direct the open end of the distal basketradially inwardly.

In accordance with still another embodiment, a method is provided forremoving, retrieving, or otherwise capturing material within a bodylumen of a patient. A basket device may be introduced into the bodylumen in a contracted condition, the basket device including a proximalbasket and a distal basket spaced apart from one another. Each of theproximal and distal baskets may include an open end communicating withan interior of the respective basket, the open ends oriented towards oneanother. The distal basket may be deployed such that the distal basketexpands within the body lumen and the open end is disposed distal tomaterial to be removed, and the proximal basket may be deployed suchthat the proximal basket expands within the body lumen and the open endis disposed proximal to material to be removed. At least one of theproximal and distal baskets may be directed towards the other to capturethe material through the open ends into interiors of the proximal anddistal baskets.

In accordance with yet another embodiment, a method for retrieving,removing, or otherwise capturing material within a body lumen of apatient. A basket device is introduced into the body lumen, e.g., in acontracted condition. The basket device may include a proximal basketand a distal basket spaced apart from one another, each of the proximaland distal baskets including an open end communicating with an interiorof the respective basket, the open ends oriented towards one another.The distal basket may be deployed such that the distal basket expandswithin the body lumen and the open end is disposed distal to material tobe removed, and the proximal basket may be deployed such that theproximal basket expands within the body lumen and the open end isdisposed proximal to material to be removed, e.g., after deploying thedistal basket. At least one of the proximal and distal baskets may bedirected towards the other to capture the material through the open endsinto interiors of the proximal and distal baskets.

In one embodiment, the open end of the distal basket may be directedradially inwardly as the at least one of the proximal and distal basketstowards the other. For example, the at least one of the proximal anddistal baskets may be directed towards the other until the open end ofthe distal basket is directed radially inwardly and received within theopen end of the proximal basket.

Optionally, the proximal basket may be directed at least partially intoa lumen of a tubular device, e.g., before withdrawing the tubular devicefrom the body lumen. For example, the proximal basket may be directedentirely into the lumen of the tubular device, e.g., thereby compressingthe proximal basket being radially inwardly as the proximal basket isdirected into the lumen of the tubular device. In addition, the proximalbasket may at least partially compress the distal basket radiallyinwardly when the proximal basket is directed into the lumen of thetubular device, e.g., allowing the distal basket to be directed into thelumen of the tubular device after the proximal basket is directed intothe lumen of the tubular device.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated that the exemplary apparatus shown in thedrawings are not necessarily drawn to scale, with emphasis instead beingplaced on illustrating the various aspects and features of theillustrated embodiments, in which:

FIG. 1 is a side view of a distal end of a first embodiment of anapparatus for capturing material from within a body lumen.

FIGS. 2A-2E are cross-sectional views of a body lumen showing a methodfor capturing material from the body lumen using the apparatus of FIG.1.

FIG. 3 is a side view of a distal end of a second embodiment of anapparatus for capturing material from within a body lumen.

FIGS. 4A-4D are side views of the distal end of the apparatus of FIG. 3,showing actuation of the apparatus to collapse a distal basket of theapparatus and capture a portion of the distal basket within a proximalbasket.

FIGS. 5A-5F are cross-sectional views of a body lumen showing a methodfor capturing material from the body lumen using the apparatus of FIG.3.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIG. 1 shows an exemplary embodiment of anapparatus 10 for removing, retrieving, and/or otherwise capturingthrombus, objects, or other material from within a body lumen, such as ablood vessel, aorto-venous fistula, tubular graft, and the like (notshown). Generally, the apparatus 10 includes an expandable basket device40 carried by a shaft or other elongate member 20, and a sheath or othertubular member 30 for facilitating delivery and/or removal of the shaft20 and basket device 40.

In the embodiment shown, the shaft 20 includes a core wire 22 and anactuator member 24 disposed adjacent the core wire 22 that are movableaxially relative to one another, the shaft 20 generally defining acentral longitudinal axis 38 for the apparatus 10. The core wire 22 maybe a substantially flexible elongate member, e.g., a solid or hollowwire structure including a proximal end (not shown) and a distal endterminating in a distal tip 26. As shown, the distal tip 26 may besubstantially atraumatic, e.g., covered by a coiled wire and/or apolymeric covering, and/or may include a “J” or other rounded shape (notshown) to minimize risk of perforation or catching during advancementwithin a patient's body.

The actuator member 24 may be an elongate tubular body including aproximal end (not shown), a distal end 28 having a size for introductioninto a body lumen, and a lumen 29 extending therebetween. The core wire22 may be slidably received within the lumen 29 such that the core wire22 extends from the lumen 29 beyond the distal end 28 and the distal tip26 is spaced apart from the distal end 28 of the actuator member 24.Alternatively, the actuator member 24 may be another elongate member,e.g., a wire or other rail (not shown) disposed adjacent to the corewire 22, as long as the actuator member 24 and core wire 22 are movableaxially relative to one another.

The core wire 22 and actuator member 24 may have sufficient length toextend from a target site within a patient's body to a location outsidethe patient's body. Alternatively, the core wire 22 and/or actuatormember 24 may extend to and be coupled to other components of theapparatus 10 spaced apart from the basket device 40. The core wire 22and/or actuator member 24 may have sufficient column strength to allowadvancement of the core wire 22 and/or actuator member 24 withoutsubstantial risk of buckling or kinking. For example, a distal region ofthe core wire 22 and actuator 24 may be relatively flexible and aproximal region may be substantially rigid or semi-rigid to facilitateadvancement of the distal region from the proximal end of the apparatus10. The core wire 22 may be formed from a single wire strand, multiplestrands, a coiled wire structure, and the like having a sufficientlysmall profile to be slidable received in the actuator member 24. Theactuator member 24 may be a formed from a hypotube, a multiple layercatheter structure, e.g., including a braid or other reinforcement andthe like.

In an exemplary embodiment, the proximal ends of the core wire 22 andactuator member 24 may be received within and/or otherwise coupled to ahandle (not shown). The handle may include an actuator, e.g., a slidercontrol, button, and the like (not shown) for directing one of the corewire 22 and actuator member 24 axially relative to the other, asexplained further below. In addition or alternatively, the handle mayinclude one or more additional controls or actuator. For example, thehandle may include an actuator for retracting the sheath 30 relative tothe basket device 40 (or advancing the basket device 40 relative to thesheath 30), also as described further below.

The basket device 40 carried by the shaft 20 generally includes a distalbasket 42 a adjacent the distal tip 26, and a proximal basket 42 bproximal to and spaced apart from the distal basket 42 a. For example,the distal basket 42 a may be attached to or otherwise fixed axiallyrelative to the core wire 22, e.g., adjacent the distal tip 26, and theproximal basket 42 b may be attached to or otherwise fixed axiallyrelative to the actuator member 24, e.g., to the distal end 28. Inaddition, in the embodiment shown, the basket device 40 includes amiddle portion 50 that extends between the distal and proximal baskets42 a, 42 b.

As shown in FIG. 1, each of the baskets 42 includes a circumferentialwall 44 defining an open end 46 communicating with an interior of thebasket 42 and a closed end 48 attached to the core wire 22 or actuatormember 24. The open ends 46 are oriented towards one another andinitially spaced apart from one another, as shown in FIG. 1. Initially,the distance between the open ends 46 may be between about five andfifty millimeters (5-50 mm), e.g., to provide sufficient space betweenthe baskets 42 to facilitate receiving material between the baskets 42for retrieval. When the actuator member 24 and core wire 22 are movedaxially relative to one another, the baskets 42 may be moved towards theother for substantially enclosing and capturing material within theinteriors of the baskets 42, e.g., as shown in FIGS. 2C-2E and describedfurther below. In addition or alternatively, the space between thebaskets 42 may be adjusted by the user, e.g., to increase or decreasethe distance between the open ends 46 before deploying the baskets 42.

In one embodiment, the baskets 42 may be expandable from a contractedcondition (not shown), e.g., sized for introduction through a patient'svasculature or other passages into a body lumen, and an expandedcondition (shown in FIG. 1), e.g., for capturing material within theopen ends 46 of the baskets 42. For example, the baskets 42 may beformed from elastic or superelastic material, such that the baskets 42may be compressed radially inwardly to the contracted condition andresiliently expand towards the expanded condition.

Alternatively, the baskets 42 may be actuatable, i.e., selectivelyexpanded and/or contracted using one or more actuators (not shown) onthe proximal end of the apparatus 10. For example, one or more balloonsor other expandable members (not shown) may be provided on the core wire22 within the baskets 42. The balloon(s) may allow the baskets 42 to beexpanded separately from one another and/or simultaneously dependingupon the number of balloons and/or inflation lumens provided in the corewire 22.

The middle portion 50 extends between the distal and proximal baskets 42a, 42 b and has a cross-section that is smaller than the proximal anddistal baskets in the expanded condition. As shown, the middle portion50 is a tubular structure that includes opposite ends 52 coupled to therespective baskets 42, e.g., by a plurality of struts 54. For example,as shown in FIG. 1, the struts 54 may be coupled to the ends 52 of themiddle portion 50 and adjacent the open ends 46 of the distal andproximal baskets 42 a, 42 b. The struts 54 may be sufficiently flexiblesuch that the middle portion 50 is movable laterally away from thecentral axis 38 relative to the distal and proximal baskets 42 l, 42 b,for example, to accommodate receiving material within a body lumenbetween the baskets 42 adjacent the middle portion 50, e.g., as shown inFIG. 2C.

In addition, the middle portion 50 may be substantially flexible suchthat the middle portion 50 is compressible axially, e.g., when thebaskets 42 are moved towards one another for capturing material withinthe interiors of the baskets 42. In addition or alternatively, thestruts 54 may be substantially flexible to provide hinges thatfacilitate receiving the middle portion 50 within the interiors of thebaskets 42 as the baskets 42 are moved towards one another.

The middle portion 50 may define a passage axially therethrough throughwhich the core wire 22 may extend. Alternatively, the core wire 22 mayextend along an exterior of or otherwise adjacent the middle portion 50.

The wall 44 of the baskets 42 and/or the middle portion 50 may be porousor otherwise include a plurality of openings 47 therein, e.g., to allowfluid to flow around and/or through the baskets 42 during use. Forexample, the baskets 42 may be formed from one or more hypotubes orother tubular bodies that have portions of the bodies removed, e.g., bylaser cutting, etching, mechanical cutting, and the like to define aplurality of struts 45 surrounding the openings 47. For example, if theactuator member 24 is formed from a hypotube or other tubular material,the proximal basket 42 b may be formed by cutting openings 47 and/orstruts 45 in an end of the tubular material and then bending theresulting structure into the shape of the proximal basket 42 b.Similarly, the middle portion 50 may also be formed from a tubular bodythat has portions removed to create a plurality of struts surroundingopenings in the middle portion 50.

Alternatively, the baskets 42 and/or middle portion 50 may be made fromone or more wires that are formed into a mesh structure, e.g., bywelding, bonding, or otherwise attaching the wire(s) together to definethe struts 45. Exemplary materials for the baskets 42 include metals,such as Nitinol or stainless steel, polymers or other plastics, orcomposite materials. The baskets 42 may be heat treated or otherwise setto be biased to the expanded condition yet resiliently compressible tothe contracted condition. For example, if the baskets 42 are formed bycutting openings 47 and/or struts 45 from individual tubular bodieshaving a cross-section similar to the contracted condition, theresulting structure may be expanded to the expanded condition and thenheat treated to program the expanded condition into the material of thestructure.

Optionally, if smaller apertures are desired, a covering (not shown) maybe placed over or within one or both of the baskets 42. Holes may bedrilled, cut, or otherwise provided in the covering, e.g., using laserdrilling, mechanical drilling, punching, and the like to provide adesired pore size. The covering may be attached to the basket(s) 42 bybonding with adhesive, heat fusion, sonic welding, interference fit, andthe like. Alternatively, a non-porous covering may be provided if flowobstruction through the wall 44 of the basket(s) 42 is desired.

As shown in FIG. 1, the baskets 42 and middle portion 50 may be definedby a plurality of zigzag struts that extend circumferentially and/oraxially around the basket device 40. For example, alternating diagonalstruts may be connected to one another about the circumference of thebaskets 42 to define a zigzag band and adjacent bands may be attached orintegrally formed together in an axially repeated pattern. For examplethe open ends 46 of the baskets 42 may define a zigzag pattern extendingaround a perimeter of the open ends 46. In one embodiment, the zigzagpatterns of at least the open ends 46 a, 46 b may be out of phase withone another such that the open ends 46 may at least partially intertwinewith one another to substantially enclose the interiors of the baskets42, e.g., as described further below.

After forming the baskets 42 and middle portion 50, the struts 54, whichmay be integrally formed with the middle portion 50 or formed separatelyand attached to the ends 52 of the middle portion 50, e.g., by welding,bonding, and the like, may be attached to the baskets 42 adjacent theopen ends 46 using similar methods. It may be useful to attach thestruts 54 extending from the ends 52 of the middle portion 50 adjacentthe open ends 46 (rather than at the open ends 46 themselves) to allowthe open ends 46 of the baskets 42 to remain free during use, e.g., whenthe baskets 42 are deployed and directed towards one another to capturematerial within the baskets 42.

In exemplary embodiments, the baskets 42 may have a diameter betweenabout half and two millimeters (0.5-2.0 mm) in the contracted conditionand a diameter between about two and nine millimeters (2.0-9.0 mm) inthe expanded condition. The middle portion 50 may have a diameterbetween about one and three millimeters (1-3 mm). For example, themiddle portion 50 may have a diameter slightly smaller than thecontracted condition, e.g., to accommodate overlap with the baskets 42,and the diameter of the middle portion 50 may remain substantiallyconstant upon expansion of the baskets 42. Alternatively, the middleportion 50 may be radially compressed into a diameter substantiallysmaller than the contracted condition of the baskets 42 and may beexpanded to a diameter smaller than the expanded condition of thebaskets 42.

As shown in FIGS. 2A and 2B, the shaft 20 and/or basket device 40 may becarried within the sheath 30, e.g., to facilitate delivery of the basketdevice 40 to a target site. The sheath 30 may include a proximal end(not shown), a distal end 34, and a lumen 36 extending therebetween.Optionally, the sheath 30 may include one or more additional lumens (notshown) extending between the proximal end and the distal end 34, e.g.,for delivering and/or aspirating fluid via the distal end 34, forreceiving a guidewire or other rail (not shown), and the like. Forexample, in some applications, it may be desirable to advance the entireapparatus 10 over a guidewire or other rail (not shown), e.g., byloading the guidewire through a guidewire lumen (also not shown)disposed adjacent the lumen 36. In addition, or alternatively, a sourceof fluid, e.g., one or more solvents or other therapeutic agents, asource of vacuum, e.g., a syringe, and the like, may be coupled to thesheath 30.

For example, as described above, the apparatus 10 may include a handle(not shown), and the proximal end of the sheath 30 may be coupled to thehandle such that the sheath 30 and/or the shaft 20 are movable axiallyrelative to one another to accommodate deploying and/or recovering thebasket device 40 during use. In addition, the handle may include one ormore ports (also not shown) for being coupled to a source of fluidand/or vacuum. The port(s) may communicate with the lumen 36 (or otherlumen, not shown, provided in the sheath 36).

During assembly or immediately before use, the shaft 20 and/or basketdevice 40 may be loaded into the lumen 36 of the sheath 30, e.g., suchthat the basket device 40 is compressed into the contracted condition.For example, the shaft 20 may be backloaded into the sheath 30 until thebaskets 42 are disposed adjacent the distal end 34 of the sheath. Thebaskets 42 may then be compressed into the contracted condition anddirected into the lumen 36, e.g., such that the baskets 42 are disposedadjacent the sheath distal end 34 with the distal tip 26 extending fromthe sheath 30, as shown in FIGS. 2A and 2B. An external constraint (notshown) may be used to compress the baskets 42 inwardly before beingloaded into the sheath 30. Alternatively, for at least the proximalbasket 42 b, the closed end 48 b may be tapered or otherwise shaped toallow the closed end 48 b to slidably engage the sheath distal end 34,thereby compressing the proximal basket 42 b inwardly as the basketdevice 40 is pulled into the sheath 30.

The proximal ends of the core wire 22, actuator member 24, and/or sheath30 may be coupled to any other necessary components of the apparatus 10,e.g., to a handle and/or actuator components, to provide an assembledapparatus 10 that may be provided to a user.

The baskets 42 (and/or middle portion 50) may be biased to resilientlyexpand to the expanded condition upon being deployed from the sheath 30.For example, as each of the baskets 42 become exposed, e.g., first thedistal basket 42 a and then the proximal basket 42 b (as describedfurther below), the baskets 42 may automatically and sequentially opentowards the expanded condition. Alternatively, the baskets 42 may beselectively expandable from the contracted to the expanded conditions,e.g., by activating an actuator on a proximal end of the apparatus 10.

If desired, the apparatus 10 may include one or more markers tofacilitate positioning and/or advancement of the apparatus 10 duringuse. For example, one or more radiopaque markers may be placed on thebasket device 10, e.g., on the open ends 46 of the baskets 42. Inaddition or alternatively, such markers may be placed at one or morelocations on the core wire 22, shaft 24, and/or sheath 40.Alternatively, the basket device 10 or components thereof may be formedfrom radiopaque or other materials that may facilitate imaging theapparatus 10 during use. For example, radiopaque markers and/ormaterials may facilitate positioning or otherwise imaging the apparatus10 using fluoroscopy or other x-ray imaging, e.g., when deploying and/oractuating the basket device 40. Alternatively, echogenic markers and/ormaterials may be provided to facilitate imaging using ultrasound orsimilar imaging techniques.

Turning to FIGS. 2A-2E, an exemplary method is shown for retrieving,removing, or otherwise capturing material 90 within a body lumen 92,e.g., using an apparatus 10, which may be any of the embodimentsdescribed herein, and not necessarily limited to the embodiment shownand described below with reference to FIG. 1. The body lumen 92 may be ablood vessel, e.g., a vein or artery, a graft, e.g., an aorto-venousfistula, tubular xenograft, or synthetic tubular graft, and the like.For example, the body lumen 92 may be a passage communicating between anadjacent artery and vein (not shown), e.g., in an arm or other region ofa dialysis patient. Alternatively, the body lumen 92 may be a bloodvessel within a patient's vasculature, e.g., a peripheral vessel in apatient's leg, a cerebral vessel, and the like. In a furtheralternative, the material 90 may be a stone within a patient's urinarytract or other foreign object to be removed from the patient's body.

Optionally, the body lumen 92 may be accessed using one or moreadditional instruments (not shown), which may be part of a system or kitincluding the apparatus 10. For example, an introducer sheath or othertubular member (not shown) may be introduced adjacent the target sitewhere the material is to be removed, or may be introduced elsewhere inthe patient's body to provide access to the patient's vasculature orother passages communicating with the body lumen 92. If the body lumen92 is located in a peripheral vessel of the patient, a percutaneouspuncture or cut-down may be created using a needle or other instrument(not shown) at a peripheral location (also not shown), such as a femoralartery, carotid artery, or other entry site, and an introducer sheathmay be placed through the puncture at the peripheral location to provideaccess. The apparatus 10 may be advanced through the patient'svasculature from the entry site, e.g., alone or with the aid of a guidecatheter 80, guidewire (not shown), and the like.

For example, to facilitate directing the apparatus 10 from an entry siteto the target body lumen 92, a guide catheter, micro-catheter, or othertubular body 80 may be placed from the entry site to the body lumen 92using conventional methods. In addition or alternatively, a guidewire(not shown) may be placed from the entry site to the body lumen 92 ifdesired, e.g., if the apparatus 10 includes a guidewire lumen in thesheath 30 or core wire 22.

Initially, as shown in FIG. 2A, the apparatus 10 has been advancedthrough the guide catheter 80 into the body lumen 92. The apparatus 10may be provided with the basket device 40 (not shown) compressed and/orretracted into the sheath 20, i.e., in the contracted condition. Forexample, the basket device 40 may be placed within the sheath 20 duringmanufacturing or immediately before the procedure by the user. Therelatively low profile of the sheath 30 and atraumatic distal tip 26 mayfacilitate advancing the apparatus 10 adjacent the material 90, e.g.,such that the distal tip 26 and distal end 34 of the sheath 30 may beadvanced through or along and distally beyond the material 90, as shownin FIG. 2B, without substantial risk of dislodging, breaking, orotherwise damaging the material 90.

Optionally, the guide catheter 80 and/or sheath 30 may facilitatedelivering one or more fluids into the body lumen 92, e.g., tofacilitate imaging and/or positioning the apparatus 10. For example,radiopaque fluid may be delivered into the body lumen 92 via the guidecatheter 80 (or via a lumen in the sheath 30, actuator member 24, orcore wire 22) to facilitate locating and/or measuring the size of thematerial 90 using fluoroscopy. Markers (not shown) on the apparatus 10may facilitate positioning the basket device 40 relative to the material90 before deployment. For example, such markers may facilitate verifyingthat the basket device 40 is positioned with the distal basket 42 adistal to the material 90 and the proximal basket 42 b proximal to thematerial 90, e.g., with the material adjacent the middle portion 50, asshown in FIGS. 2B and 2C, before deployment. If desired, the spacing ofthe distal and proximal baskets 42 a, 42 b may be adjusted based uponthe size of the material 90 encountered. For example, if the length ofthe material 90 is greater than the initial spacing of the baskets 42within the sheath 30, the core wire 22 or actuator member 24 may bedirected axially to increase the spacing between baskets 42 to ensurethat the open ends are located proximally and distally sufficiently fromthe material 90 upon deployment.

The basket device 40 may then be deployed within the body lumen 92,e.g., such that the material to be removed or captured is disposedwithin or adjacent the basket device 40, as shown in FIG. 2C. Forexample, the sheath 30 may be retracted, thereby deploying the distalbasket 42 a beyond the material 90 and then deploying the proximalbasket 42 b proximal to the material 90. As described above, the baskets42 may resiliently and/or automatically expand upon being exposed withinthe body lumen 92. In addition or alternatively, the baskets 42 may beselectively expanded within the body lumen 92. For example, a balloon orother expandable member (not shown) may be expanded to expand thebaskets 42 independently of one another or simultaneously. In theexpanded condition, the open ends 46 may substantially engage or contactthe wall of the body lumen 92, e.g., to prevent material 90 capturedbetween the proximal and distal baskets 42 from being released.

As shown, the middle portion 50 of the basket device 40 may be disposedadjacent the material 90 upon deployment, e.g., being pushed laterallyto one side of the body lumen 92 by the material 90. For example, thestruts 54 connecting the middle portion 50 to the baskets 42 may bend orotherwise provide sufficient flexibility to accommodate this lateralmovement of the middle portion 50, if desired. The openings in themiddle portion 50 may partially capture or engage the material 90, e.g.,to at least partially secure the material 90 to the middle portion 50,which may reduce the risk of material 90 breaking free from the basketdevice 40. Optionally, if desired, the middle portion 50 may includeother structures and/or materials, e.g., strands, fibers, and the like(not shown), in addition to or instead of the tubular structure shown,which may enhance securing the material 90 to the middle portion 50.

Turning to FIG. 2D, if desired, the material 90 may be treated, e.g., atleast partially dissolved, macerated, and the like before or afteractuation of the basket device 40. For example, a therapeutic agent maybe delivered into the body lumen 92 via the guide catheter 80 (or aninfusion lumen in one of the members of the apparatus 10). The middleportion 50 of the basket device 40 may ensure a passage through and/orbeyond the material 90, which may enhance treatment of the material 90along its entire length within the body lumen 92. The porous, openconfiguration of the basket device 40 may also facilitate such treatmentof the material 90. For example, if the material 90 is thrombus or otherrelatively soft material, the material 90 may be compressed within thebasket device 40 such that portions of the material 90 pass through theopenings 47 in the basket device 40. This may increase exposed surfacearea of the material 90 increasing the effectiveness of any therapeuticagent introduced into the body lumen 92. Optionally, vacuum may beapplied via the guide catheter 80 (or one of the members of theapparatus 10), e.g., to aspirate any therapeutic agent(s), dissolved orseparated material 90, and the like, before or after actuating thebasket device 40.

In addition, if the middle portion 50 is a tubular structure, the middleportion 50 may provide a flow passage across the material 90. Forexample, if the material 90 is clot, thrombus, and the like partially orentirely obstructing the body lumen 92, deployment of the middle portion50 may immediately provide a flow path for blood across the material 90.Such blood flow may reduce or eliminate an ischemic condition of tissuesdownstream from the obstruction or provide other immediate benefit tothe patient.

Turning to FIG. 2E, the basket device 40 may then be actuated to capturethe material 90 within the baskets 42, e.g., to minimize liberation ofthe material 90 during removal. For example, the core wire 22 may bedirected proximally, thereby pulling the distal basket 42 a towards theproximal basket 42 b, e.g., until the open ends 46 contact or areotherwise disposed immediately adjacent one another. Alternatively, theactuator member 24 may be directed distally to push the proximal basket42 b distally towards the distal basket 42 a. As shown, the zigzagshapes of the open ends 46 are offset from one another such that thebaskets 42 may engage or become entwined with one another to enhanceentrapment of the material 90 within the basket device 40. Optionally,the open ends 46 may include detents or other features that may lock orotherwise secure the open ends 46 together to prevent subsequentseparation of the baskets 42. The struts 54 and/or the middle portion 50may bend or otherwise deform to facilitate receiving the middle portion50 within the interiors of the baskets 42 along with the material 90captured therein.

The apparatus 10 may then be withdrawn from the body lumen 92 along withthe material 90 captured within the basket device 40. For example, theapparatus 10 may be pulled until the proximal basket 42 b contacts theguide catheter 80, whereupon the guide catheter 80 and apparatus 10 maybe withdrawn from the body lumen 92 and/or entirely from the patient'sbody. Alternatively, the apparatus 10 may be directed such that thebasket device 40 at least partially enters the guide catheter 80. Forexample, the closed end 48 b of the proximal basket 42 b may be tapered,as shown, thereby causing the proximal basket 42 b to compress radiallyinwardly towards the contracted condition as it is directed into theguide catheter 80. If the open ends 46 of the baskets 42 aresufficiently entwined, as the proximal basket 42 b is compressed, thedistal basket 42 a may also become compressed, thereby allowing theentire basket device 40 to be compressed and pulled into the guidecatheter 80 with the material 90.

In addition or alternatively, a source of aspiration may be coupled tothe guide catheter 80 and activating to pull the captured material 90into the guide catheter 80 and from the patient's body. For example, theaspiration may pull the material 90 through the openings 47 in thebasket device 40, thereby breaking the material 90 into smaller portionsthat may be more easily drawn into the guide catheter 80. Thisaspiration may also be enhanced by delivering a solvent or othertherapeutic agent via the guide catheter 80 to further break up ordissolve the material 90.

With the material 90 aspirated and/or the basket device 40 partially orentirely withdrawn into the guide catheter 80, the guide catheter 80 andany remaining components of the apparatus 10 may be removed from thebody lumen 92 and/or the patient's body. The process may be repeated, asdesired, using the same apparatus 10 or a different apparatus (notshown). For example, the basket device 40 may be withdrawn into thesheath 30 and then directed to another location within the body lumen 92or other elsewhere, and then redeployed to capture additional material,and the process may be repeated as often as desired. Alternatively,another apparatus 10 may be introduced into the body lumen 92 or otherlocation before closing the entry site, as desired.

Turning to FIGS. 3-4D, another embodiment of an apparatus 110 is shownfor removing, retrieving, or otherwise capturing material within a bodylumen. Generally, the apparatus 110 includes an expandable basket device140 carried by a shaft or other elongate member 120, and a sheath,micro-catheter, or other tubular member 130 (not shown, see, e.g., FIGS.5A-5E) for facilitating delivery and/or removal of the shaft 120 andbasket device 140, similar to the previous embodiments. For example, theshaft 120 includes a core wire 122 and an actuator member 124 disposedadjacent the core wire 122 that are movable axially relative to oneanother. The core wire 122 may be a substantially flexible elongatemember terminating in a distal tip 126, and the actuator member 124 maybe an elongate tubular body including a proximal end (not shown), adistal end 128 having a size for introduction into a body lumen, and alumen 129 for slidably receiving the core wire 122 therein, e.g., alsosimilar to the previous embodiments.

The basket device 140 carried by the shaft 120 generally includes adistal basket 142 a adjacent the distal tip 126, and a proximal basket142 b proximal to and spaced apart from the distal basket 142 a. Forexample, the distal basket 142 a may be attached to or otherwise fixedaxially relative to the core wire 122, e.g., adjacent the distal tip126, and the proximal basket 142 b may be attached to or otherwise fixedaxially relative to the actuator member 124, e.g., to the distal end128.

As shown in FIG. 3, each of the baskets 142 includes a circumferentialwall 144 defining an open end 146 communicating with an interior of thebasket 142 and a closed end 148 attached to the core wire 122 oractuator member 124. The open ends 144 are oriented towards one anotherand initially spaced apart from one another, as shown in FIG. 3, and theclosed ends 148 are oriented away from one another. When the actuatormember 124 and core wire 122 are moved axially relative to one another,one or the baskets 142 may be moved towards the other for substantiallyenclosing the interiors of the baskets 142, e.g., as shown in FIGS.4A-4D and described further below.

Also similar to the previous embodiment, the baskets 142 may beexpandable from a contracted condition (not shown), e.g., sized forintroduction through a patient's vasculature or other passages into abody lumen, and an expanded condition (shown in FIG. 3), e.g., forcapturing material within the interiors of the baskets 142. For example,the baskets 142 may be formed from elastic or superelastic material,such that the baskets 142 may be compressed radially inwardly to thecontracted condition and resiliently expand towards the expandedcondition, similar to the previous embodiments.

The wall 144 of the baskets 142 may be porous or otherwise include aplurality of openings 147 therein, e.g., to allow fluid to flow aroundand/or through the baskets 142 during use, similar to the previousembodiments. For example, as best seen in FIGS. 5C-5F, the baskets 142may include a plurality of struts 145 surrounding openings 147. Thebaskets 142 may be formed from one or more hypotubes or other tubularmaterial, e.g., by laser-cutting or otherwise removing material todefine the struts 145 and openings 147, or formed from one or more wiresthat are cut, bent, or otherwise formed into the desired mesh structurefor the baskets 142 b, similar to the previous embodiments.

Unlike the previous embodiments, the distal basket 142 a includes one ormore elements 150 extending from the open end 146 a to a collar 152slidable on the core wire 122. For example, the elements 150 may includea plurality of struts extending from the open end 146 a longitudinallyalong the inside of the wall 144 a of the distal basket towards theclosed end 148 a, and then bending or curving inwardly to the collar152. As shown, the elements 150 include at least two struts spaced apartabout the circumference of the distal basket 142 a, although only one orseveral struts may be provided, as desired. Thus, the elements 150 maycouple the open end 146 a to the collar 152 without substantiallyobstructing the interior of the distal basket 142 a. Alternatively, theelements 150 may extend diagonally or radially inwardly (not shown) fromthe open end 146 a to the collar 152, as long as the elements 150 allowthe distal basket 142 a to be compressed and expanded between thecontracted and expanded conditions.

The collar 152 may be slidable disposed around the core wire 122, whilethe closed end 148 a of the distal basket 142 a is substantially fixedto the core wire 122. Thus, the collar 152 may be slidable distallytowards the closed end 148 a to direct the open end 146 a radiallyinwardly, as described further below.

In one embodiment, the distal basket 142 a, elements 150, and collar 152may be integrally formed from a single structure, e.g., a laser-cut tubewith the collar 152 and elements 150 initially extending axially beyondthe open end 146 a of the distal basket 142 (not shown). The collar 152and elements 150 may then be bent or otherwise deformed to position thecollar within the interior of the distal basket 142 a and the elementsalong the inside of the wall 144 a, and the material heat treated orotherwise to program the desired shape. Alternatively, the collar 152,elements, 150, and/or distal basket 142 a may be formed from separatecomponents that are attached together, e.g., by welding, bonding, andthe like.

Also unlike the previous embodiments, the proximal basket 142 b isattached to the actuator member 124 proximal to the distal end 128. Forexample, as shown in FIG. 3, the closed end 148 b of the proximal basket142 b may be attached to the actuator member 124 proximal to the distalend 128 of the actuator member 124, e.g., such that the distal end 128extends distally at least partially through the interior of the proximalbasket 142 b. Alternatively, a separate tubular member or other feature(not shown) may be attached to the closed end 148 b of the proximalbasket 142 b and/or to the distal end 128 of the actuator member 124such that the feature extends axially through the proximal basket 142 b.The distal 128 (or separate feature) may extend distally over the corewire 122 through the interior of the proximal basket 142 b towards theinterior of the distal basket 142 a. For example, as shown in FIG. 3,the distal end 128 of the actuator member 124 may extend into theinterior of the distal basket 142 a such that the distal end 128 isadjacent but spaced apart from the collar 152.

Turning to FIGS. 4A-4D, the distal end 128 of the actuator member 124and collar 152 may provide a mechanism for compressing the open end 146a of the distal basket 142 a during use. For example, as shown in FIG.4A, the distal end 128 of the actuator member 124 may be spaced apartfrom the collar 152 by a distance that is less than the distance betweenthe open ends 146 of the distal and proximal baskets 142. Although theopen ends 146 of the baskets 142 are shown to be relatively close to oneanother compared to the length of the baskets 142, it will beappreciated that the spacing is not shown to scale, and that the openends 146 may be spaced apart any desired distance, e.g., to accommodatereceiving material between the baskets 142 during use, as describedelsewhere herein.

As shown in FIG. 4B, when the core wire 122 is pulled proximallyrelative to the actuator member 124 (or the actuator member 124 isadvanced distally) to direct the baskets 142 towards one another, thedistal end 128 and collar 152 may contact one another before the openends 146 of the baskets 142 contact one another, i.e., the open ends 146may yet be spaced apart from one another. As the core wire 122 oractuator member 124 is actuated further, the distal end 128 may contactthe collar 152 and cause the collar 152 to be directed towards theclosed end 148 a of the distal basket 142 a, as shown in FIG. 4C. Thisaction applies tension to the elements 150 coupled to the open end 146 aof the distal basket 142 a, thereby applying a radially inward force onthe open end 146 a.

As shown, thinned or weakened regions, hinges, or other bend features154 may be provided on the struts of the distal basket 142 a adjacent tothe open end 146 a. For example, the struts defining the circumferentialwall 144 a of the distal basket 142 a may have their width and/orthickness reduced relative to the other struts, e.g., by machining,etching, and the like. These preferential bend features 154 may causethe distal basket 146 a to bend inwardly at these features 154, as shownin FIG. 4C. Alternatively, if no bend features 154 are provided, thedistal basket 142 a may bend inwardly at other locations along thecircumferential wall 144 a, e.g., at the transition between the closedend 148 a and the circumferential wall 144 a (not shown). Thus, thedeformation of the distal basket 142 a may be distributed along itslongitudinal length, or it may be concentrated at the preferential bendfeatures 154.

Turning to FIG. 4D, as the core wire 122 or actuator member 124 areactuated further, the axial positions of the baskets 142 continue toconverge, and as the open end 146 a of the distal basket 142 deformsradially inward, the open ends 146 begin to overlap. For example, theopen end 142 a of the distal basket 142 may be deformed radiallyinwardly until it contacts the actuator member 124, although the openend 142 a may be spaced radially away from the actuator member 124, ifdesired. As shown, the degree of inward radial deformation of the openend 146 a of the distal basket 142 a may be sufficient such that theopen end 142 a may extend into the open end 146 b of the proximal basket142 b. In doing so, the edges of the open end 146 a of the distal basket142 a may be presented as the basket device 140 is retracted, e.g., intothe delivery sheath 130 (see, e.g., FIGS. 5A-5E), guide catheter 80, orother device, and/or removed from the body lumen 92 and/or the patient'sbody.

In addition, the overlap of the proximal basket 142 b partially over thedistal basket 142 a may facilitate directing the basket device 140 backto the contracted condition, e.g., to facilitate removal. For example,if the basket device 140 in the configuration shown in FIG. 4D isretracted into the guide catheter 80, as shown in FIG. 5F (or,alternatively, into the delivery sheath 130 or other device, not shown),the closed end 148 b of the proximal basket 142 b may be tapered toallow the proximal basket 142 b to be compressed radially inwardly as itis drawn into the guide catheter 80. The open end 146 b of the proximalbasket 142 b may press inwardly against the open end 146 a of the distalbasket 142 a, thereby causing the distal basket 142 a to also becompressed radially inwardly. Optionally, the baskets 142 may becompressed inwardly back to the original contracted condition or othersize sufficiently small to allow withdrawal partially or entirely intothe guide catheter 80.

Turning to FIGS. 5A-5F, an exemplary method is shown for retrieving,removing, or otherwise capturing material 90 within a body lumen 92using the apparatus 110. Similar to the previous methods, the material90 may be a foreign body, or a result of undesirable biologicalprocesses such as thrombus within the vasculature or stones within theurinary tract.

Initially, as shown in FIG. 5A, the apparatus 110 is provided within thebasket device 140 (not shown, see FIGS. 5C-5F) within the sheath 130 inthe contracted condition. The apparatus 110 has been advanced through aguide catheter 80 into the body lumen 92 such that the distal tip 126 isadjacent the material 90. Turning to FIG. 5B, the apparatus 110 may beadvanced at least partially past the material 90, .e.g., such that thedistal tip 126 and the distal basket 142 a (not shown) within the sheath130 is positioned distally beyond the material 90. Similar to theprevious embodiments, the relatively low profile of the sheath 130 andatraumatic distal tip 126 may facilitate advancing the apparatus 100adjacent or through the material 90 without substantial risk ofdislodging, breaking, or otherwise damaging the material 90.

Optionally, the guide catheter 80 and/or sheath 130 may facilitatedelivering one or more fluids into the body lumen 92, e.g., tofacilitate imaging and/or positioning the apparatus 110 and/or material90, similar to the previous embodiments. For example, markers (notshown) may be provided on the apparatus 110 to facilitate positioningthe basket device 140 relative to the material 90 before deployment,also similar to the previous embodiments.

Turning to FIG. 5C, the basket device 140 may then be deployed withinthe body lumen 92, e.g., such that the material to be removed orcaptured is disposed within or adjacent the basket device 140. Forexample, with the distal end 134 of the sheath 130 disposed adjacent ordistally beyond the material, the core wire 122 may be advanced, therebydeploying the distal basket 142 a beyond the material 90. With theproximal basket 142 b remaining within the sheath 130, the apparatus 110may be manipulated further, e.g., to position the distal basket 142 aimmediately adjacent the material 90 and/or with the material 90 atleast partially captured within the open end 146 a of the distal basket142 a.

The proximal basket 142 b may then be deployed proximal to the material90, e.g., by retracting the sheath 130 or advancing the actuator member134. As described above, the baskets 142 may resiliently and/orautomatically expand upon being exposed within the body lumen 92. In theexpanded condition, the open ends 146 may substantially engage orcontact the wall of the body lumen 92, e.g., to prevent material 90captured between the proximal and distal baskets 142 from beingreleased.

As can be seen in FIG. 5D, the core wire 122 extends through theinterior of the distal basket 142 a with the collar 152 free to slidealong the core wire 122 to accommodate expansion of the open end 146 aof the distal basket 142 a. The distal end 128 of the actuator member124 is spaced substantially away from the collar 152, i.e., proximallybeyond the open end 146 a of the distal basket 142 a since the proximalbasket 142 b is positioned a substantial distance proximal to the distalbasket 142 a. As shown, the core wire 122 may be disposed in a generallyconcentric position with respect to the body lumen 92 and the baskets142. Alternatively, if desired, the core wire 122 may be positioned inan eccentric position, e.g., by modifying the shape of the closed ends148 of the baskets 142, such that the core wire 122 extends along oneside of the walls 144 of the baskets 142 (not shown).

Turning to FIG. 5E, the basket device 140 may then be actuated tocapture the material 90 within the baskets 142, e.g., to minimizeliberation of the material 90 during removal. For example, the actuatormember 124 may be advanced distally to direct the proximal basket 142 bdistally towards the distal basket 142 a, e.g., to capture material 90within the interior of the baskets 142. In particular, with additionalreference to FIGS. 4A-4D, the actuator member 124 may be advanced untilthe distal end 128 of the actuator member 122 contacts and pushes thecollar 152 distally, thereby compressing the open end 146 a of thedistal basket 142 a radially inwardly and into the open end 146 b of theproximal basket 14 b. Thus, as shown in FIG. 5E, as a result, thematerial 90 may be substantially captured within the baskets 142 tominimize risk of release of the material 90.

Finally, as shown in FIG. 5F, the apparatus 110 may then be withdrawnfrom the body lumen 92 along with the material 90 captured within thebasket device 140. For example, as shown, the apparatus 110 may bepulled until the basket device 140 is at least partially received withinthe guide catheter 80. As the proximal basket 142 b contacts the guidecatheter 80, the proximal basket 142 b may be compressed radiallyinwardly towards the contracted condition as it is pulled into the guidecatheter 80. As this motion continues, the distal basket 142 a may alsobe withdrawn into the guide catheter 80 without hanging up because theleading edge of the open end 146 a is contained within the proximalbasket 142 b, and thus does not present any sharp or blunt edges.Furthermore, none of the struts or leading edges of the open end 146 aof the distal basket 142 a are likely to protrude through the openings147 b of the proximal basket 142 b because they are radially deformedinwardly toward the core wire 122.

The guide catheter 80 with the apparatus 110 therein may be withdrawnfrom the body lumen 92 and entirely from the patient's body with thebaskets 142 completely contained within the guide catheter 80.Alternatively, if desired, the basket device 140 may only be partiallywithdrawn into the guide catheter 80 before removal from the patient'sbody. In a further alternative, the apparatus 110 may be removed fromthe body lumen 92 and/or entirely from the patient's body withoutwithdrawing the basket device 140 into the guide catheter 80. In thisalternative, bending and capturing the open end 146 a of the distalbasket 142 a within the proximal basket 142 b may ensure that no bluntor sharp edges are presented on the leading edge of the distal basket142 a, which may facilitate retracting the apparatus 110 through otherdevices (such as an arterial access introducer sheath, not shown) orotherwise along the delivery path through the patient's vasculature,e.g., along various body lumens and/or tissue punctures through whichthe apparatus 110 was originally tracked when accessing the target bodylumen 92.

Optionally, one or more therapeutic agents may be delivered and/or fluidmay be aspirated at any time via the guide catheter 80 or component ofthe apparatus 110, similar to the previous embodiments.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for retrieving material within a body lumen, comprising:an elongate member including a proximal end, a distal end sized forintroduction into a body lumen, and terminating in a distal tip; and abasket device carried on the distal end comprising a distal basketadjacent the distal tip and a proximal basket proximal to and spacedapart from the distal basket, each basket comprising an open endcommunicating with an interior of the respective basket, the open endsoriented towards one another, at least one of the baskets being movabletowards the other for substantially enclosing and capturing materialwithin the interiors of the baskets.
 2. The apparatus of claim 1,wherein the baskets are expandable from a contracted condition sized forintroduction into a body lumen and an expanded condition sized forcapturing material within the open ends of the baskets.
 3. The apparatusof claim 2, further comprising a tubular member comprising a proximalend, a distal end sized for introduction into a body lumen, and a lumenextending between the tubular member proximal and distal ends, thebasket device disposed within the lumen in the contracted condition suchthat the elongate member extends proximally within the lumen, theelongate member being movable relative to the tubular member fordeploying the basket device from the tubular member distal end.
 4. Theapparatus of claim 3, wherein the baskets are directable to thecontracted condition for placement within the tubular member lumen, andbiased to resiliently expand to the expanded condition upon beingdeployed from the tubular member.
 5. The apparatus of claim 1, whereineach basket comprises a circumferential wall and a closed end oppositethe open end, the circumferential wall comprising a plurality ofopenings therein.
 6. The apparatus of any preceding claim 1, wherein thebaskets are formed from a mesh structure.
 7. (canceled)
 8. The apparatusof claim 1, wherein the basket device comprises a middle portionextending between the proximal and distal baskets and having across-section that is smaller than the proximal and distal baskets inthe expanded condition.
 9. The apparatus of claim 8, wherein the middleportion comprises a mesh tubular structure.
 10. The apparatus of claim9, wherein the middle portion is coupled to the proximal and distalbaskets by a plurality of struts.
 11. The apparatus of claim 10, whereinthe struts are coupled to ends of the middle portion and adjacent theopen ends of the proximal and distal baskets.
 12. The apparatus of claim10, wherein the struts are sufficiently flexible such that the middleportion is movable laterally relative to the proximal and distal basketsto accommodate receiving material within a body lumen between theproximal and distal baskets adjacent the middle portion.
 13. Theapparatus of claim 8, wherein the middle portion is substantiallyflexible such that the middle portion is compressible axially when theproximal and distal baskets are moved towards one another for capturingmaterial within the interiors of the baskets.
 14. The apparatus of claim1, wherein the open ends of the proximal and distal baskets comprises azigzag pattern extending around a perimeter of the open ends, the zigzagpatterns of the open ends being out of phase with one another such thatthe open ends may at least partially intertwine with one another tosubstantially enclose the interiors of the baskets.
 15. The apparatus ofclaim 1, further comprising an actuator coupled to the open end of thedistal basket such that when the at least one of the baskets is movedtowards the other, the actuator is activated to cause the open end ofthe distal basket to compress radially inwardly.
 16. The apparatus ofclaim 15, wherein the actuator comprises: a collar slidable axiallyalong a core wire of the shaft; and one or more elements extending fromthe open end of the distal basket to the collar, wherein the shaftcomprises an actuator member that contacts the collar when the at leastone of the baskets is moved towards the other, thereby applying aninward tension on the one or more elements to compress the open end ofthe distal basket radially inwardly.
 17. The apparatus of claim 15,wherein the actuator is activated before the at least one of the basketsis moved entirely towards the other such that the open end of the distalbasket is compressed radially inwardly and received in the open end ofthe proximal basket. 18-20. (canceled)
 21. An apparatus for retrievingmaterial within a body lumen, comprising: a core wire comprising aproximal end and a substantially atraumatic distal tip; an actuatormember adjacent the core wire and comprising a distal end disposedproximal to the distal tip, the actuator member movable distallyrelative to the core wire; and a distal basket fixed relative to thecore wire adjacent the distal tip, the distal basket comprising aproximal open end and a distal enclosed end defining an interior of thedistal basket; a proximal basket fixed relative to the distal end of theactuator member, the proximal basket comprising a distal open end and aproximal enclosed end defining an interior of the proximal basket, theproximal basket movable distally towards the distal basket when theactuator member is moved distally relative to the core wire forsubstantially enclosing and capturing material within the interiors ofthe baskets; and a middle portion extending between the proximal anddistal baskets and having a cross-section that is smaller than theproximal and distal baskets in the expanded condition, the middleportion compressible axially when the proximal basket is moved distallytowards the distal basket.
 22. The apparatus of claim 21, furthercomprising a tubular member comprising a proximal end, a distal endsized for introduction into a body lumen, and a lumen extending betweenthe tubular member proximal and distal ends, the proximal and distalbaskets disposed within the lumen in a contracted condition such thatthe actuator member and core wire extend proximally within the lumen,the tubular member being movable relative to the proximal and distalbaskets for deploying the proximal and distal baskets from the tubularmember distal end such that the proximal and distal baskets resilientlyexpand to an expanded condition.
 23. The apparatus of claim 22, whereinthe baskets are directable to the contracted condition for placementwithin the tubular member lumen, and biased to resiliently expand to theexpanded condition upon being deployed from the tubular member.
 24. Theapparatus of claim 21, wherein each basket comprises a circumferentialwall and a closed end opposite the open end, the circumferential wallcomprising a plurality of openings therein.
 25. The apparatus of claim21, wherein the middle portion is coupled to the proximal and distalbaskets by a plurality of struts.
 26. An apparatus for retrievingmaterial within a body lumen, comprising: a core wire comprising aproximal end and a substantially atraumatic distal tip; an actuatormember adjacent the core wire and comprising a distal end disposedproximal to the distal tip, the actuator member movable distallyrelative to the core wire; and a distal basket fixed relative to thecore wire adjacent the distal tip, the distal basket comprising aproximal open end and a distal enclosed end defining an interior of thedistal basket; a proximal basket fixed relative to the distal end of theactuator member, the proximal basket comprising a distal open end and aproximal enclosed end defining an interior of the proximal basket, theproximal basket movable distally towards the distal basket when theactuator member is moved distally relative to the core wire forsubstantially enclosing and capturing material within the interiors ofthe baskets; and an actuator collar slidable on the core wire within theinterior of the distal basket, the collar coupled to the open end of thedistal basket such that, when the actuator member is moved distallyrelative to the core wire, the collar applies an inward force to directthe open end of the distal basket radially inwardly.
 27. The apparatusof claim 26, further comprising a tubular member comprising a proximalend, a distal end sized for introduction into a body lumen, and a lumenextending between the tubular member proximal and distal ends, theproximal and distal baskets disposed within the lumen in a contractedcondition such that the actuator member and core wire extend proximallywithin the lumen, the tubular member being movable relative to theproximal and distal baskets for deploying the proximal and distalbaskets from the tubular member distal end such that the proximal anddistal baskets resiliently expand to an expanded condition.
 28. Theapparatus of claim 27, wherein the baskets are directable to thecontracted condition for placement within the tubular member lumen, andbiased to resiliently expand to the expanded condition upon beingdeployed from the tubular member.
 29. The apparatus of claim 26, whereineach basket comprises a circumferential wall and a closed end oppositethe open end, the circumferential wall comprising a plurality ofopenings therein.
 30. The apparatus of claim 26, wherein the collar iscoupled to the open end of the distal basket by one or more struts. 31.A method for removing material within a body lumen of a patient,comprising: introducing a basket device into the body lumen in acontracted condition, the basket device comprising a proximal basket anda distal basket spaced apart from one another, each of the proximal anddistal baskets comprising an open end communicating with an interior ofthe respective basket, the open ends oriented towards one another;deploying the distal basket such that the distal basket expands withinthe body lumen and the open end is disposed distal to material to beremoved; deploying the proximal basket such that the proximal basketexpands within the body lumen and the open end is disposed proximal tomaterial to be removed; and directing at least one of the proximal anddistal baskets towards the other to capture the material through theopen ends into interiors of the proximal and distal baskets. 32-45.(canceled)